ID
37505
Beschreibung
Study ID: 110269 Clinical Study ID: 110269 Study Title: An open label positron emission tomography study in healthy male subjects to investigate brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00814957 Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: positron emission tomography, GSK618334 Study Indication: Substance Dependence
Stichworte
Versionen (2)
- 26.07.19 26.07.19 -
- 04.08.19 04.08.19 -
Rechteinhaber
GlaxoSmithKline
Hochgeladen am
4. August 2019
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Brain Dopamine D3 receptor occupancy, pharmacokinetics and safety of single oral doses of GSK618334, using 11C-PHNO as PET ligand NCT00814957
Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events; Concomitant Medication; Electronically Transferred Lab Data; Vital Signs; 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood - GSK618334
Beschreibung
Logs and Repeats - Adverse event/ Concomitant Medication/ Repeat Assessment Check Questions
Alias
- UMLS CUI-1
- C1708728
- UMLS CUI-2
- C0205341
- UMLS CUI-3
- C0877248
- UMLS CUI-4
- C1516048
- UMLS CUI-5
- C2347852
- UMLS CUI-6
- C1516048
Beschreibung
Were any concomitant medications taken by the subject during the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2347852
Beschreibung
Did the subject experience any non-serious adverse events during the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1518404
Beschreibung
Did the subject experience any serious adverse events during the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Were any abnormal ECG measurements recorded for this subject during the study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0522055
Beschreibung
Were any repeat haematology or clinical chemistry samples taken?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0018941
- UMLS CUI [1,2]
- C0200345
Beschreibung
Were any repeat urinalysis samples taken?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C0200345
- UMLS CUI [1,3]
- C0205341
Beschreibung
Were any repeat ECGs performed?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1623258
- UMLS CUI [1,2]
- C0205341
Beschreibung
Were any repeat vital signs recorded?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0205341
Beschreibung
Were any repeat PK blood samples taken?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1277698
- UMLS CUI [1,2]
- C0031327
- UMLS CUI [1,3]
- C0205341
Beschreibung
Was any Holter monitoring performed?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0013801
Beschreibung
If liver event occurred, stop investigational product, complete date stopped on Investigational Product form and contact GSK within 24 hours of occurrence of liver event by phone or fax. If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSl<. *Obtain tests as per protocol *Obtain blood samples for Pharmacokinetics (PK) analysis within 24 hours or 3 ha|f—|ives {insert vaiue of whichever is ionger} of last dose *Complete Liver Event Forms (compieted Liver Event Forms do not need to be supplied to GSK within 24 hours) If Yes to Liver Events, go to the LE DETAILS visit and complete the Liver Event forms.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C2746065
- UMLS CUI [2,3]
- C0243161
Beschreibung
Non-serious Adverse Event (AE)
Alias
- UMLS CUI-1
- C1518404
Beschreibung
Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
Diagnosis Only (if known) Otherwise Sign/Symptom
Datentyp
text
Alias
- UMLS CUI [1]
- C0877248
Beschreibung
Modified term
Datentyp
text
Alias
- UMLS CUI [1]
- C2826302
Beschreibung
MedDRA synonym
Datentyp
text
Alias
- UMLS CUI [1]
- C1140263
Beschreibung
MedDRA lower level term code
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
Failed coding
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Non-serious Adverse Event Start Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C1301880
Beschreibung
Non-serious Adverse Event Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C1705586
Beschreibung
Non-serious Adverse Event End Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C1522314
Beschreibung
Non-serious Adverse Event Frequency
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0439603
Beschreibung
Non-serious Adverse Event Maximum Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0518690
Beschreibung
Non-serious Adverse Event Maximum Grade
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beschreibung
Non-serious Adverse Event Maximum Grade or Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [2,1]
- C1518404
- UMLS CUI [2,2]
- C0518690
- UMLS CUI [2,3]
- C0806909
Beschreibung
Action Taken with Investigational Product(s) as a Result of the AE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1518404
Beschreibung
Did the subject withdraw from study as a result of this AE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1518404
Beschreibung
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
Duration of AE if < 24 hours
Datentyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beschreibung
Time to Onset Since Last Dose
Datentyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Beschreibung
Serious Adverse Events (SAE)
Alias
- UMLS CUI-1
- C1519255
Beschreibung
Initial Report
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0684224
- UMLS CUI [1,2]
- C0205265
Beschreibung
Follow-Up Report
Datentyp
integer
Alias
- UMLS CUI [1]
- C1704685
Beschreibung
Did SAE occur after initiation of study medication?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0304229
Beschreibung
SAE Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschreibung
Diagnosis Only (if known) Otherwise Sign/Symptom
Datentyp
text
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Modified term
Datentyp
text
Alias
- UMLS CUI [1]
- C2826302
Beschreibung
MedDRA synonym
Datentyp
text
Alias
- UMLS CUI [1]
- C1140263
Beschreibung
MedDRA lower level term code
Datentyp
text
Alias
- UMLS CUI [1]
- C3898442
Beschreibung
Failed coding
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Serious Adverse Events Start Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0808070
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1301880
Beschreibung
Serious Adverse Events Outcome
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1705586
Beschreibung
Serious Adverse Events End Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0806020
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C1522314
Beschreibung
Serious Adverse Events Maximum Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0518690
- UMLS CUI [1,3]
- C0806909
Beschreibung
Serious Adverse Event Maximum Grade
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
Beschreibung
Serious Adverse Event Maximum Grade or Intensity
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0806909
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0518690
- UMLS CUI [2,3]
- C0806909
Beschreibung
Action Taken with Investigational Product(s) as a Result of the AE
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1704758
- UMLS CUI [1,2]
- C1519255
Beschreibung
Did the subject withdraw from study as a result of this AE?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1710677
- UMLS CUI [1,2]
- C1519255
Beschreibung
Is there a reasonable possibility that the AE may have been caused by the investigational product?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0013230
- UMLS CUI [1,3]
- C0439849
Beschreibung
Duration of AE if < 24 hours
Datentyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0449238
Beschreibung
Time to Onset Since Last Dose
Datentyp
durationDatetime
Alias
- UMLS CUI [1,1]
- C0332162
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C3174092
- UMLS CUI [1,4]
- C1517741
Beschreibung
Was SAE caused by activities related to study participation (e.g. procedures)?
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C3641099
- UMLS CUI [1,2]
- C1519255
Beschreibung
Was the event serious?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
Check all that apply.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C0392360
Beschreibung
Serious Adverse Event - Concomitant Medication
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C2347852
Beschreibung
CM Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2348184
Beschreibung
(Trade Name preferred)
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Dose
Datentyp
text
Alias
- UMLS CUI [1]
- C3174092
Beschreibung
Unit
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Frequency
Datentyp
integer
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
Route
Datentyp
integer
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Concomitant Medication Start Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826734
Beschreibung
Concomitant Medication Ongoing?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
If concomitant medication not ongoing, specify end date
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2826666
- UMLS CUI [1,2]
- C2826744
Beschreibung
Concomitant medication Primary Indication
Datentyp
text
Alias
- UMLS CUI [1]
- C2826696
Beschreibung
Drug Type
Datentyp
integer
Alias
- UMLS CUI [1]
- C0457591
Beschreibung
Serious Adverse Event - Medical Conditions/ Risk Factors
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0012634
- UMLS CUI-3
- C0035648
Beschreibung
MHx Sequence Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0262926
Beschreibung
Specific Condition Name
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C2348235
Beschreibung
Date of onset
Datentyp
datetime
Alias
- UMLS CUI [1]
- C0574845
Beschreibung
Medical Conditions/ Risk Factors Continuing?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0549178
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0549178
Beschreibung
If Medical Conditions/ Risk Factors not Continuing, specify date of last occurence
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0012634
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [1,3]
- C2745955
- UMLS CUI [2,1]
- C0035648
- UMLS CUI [2,2]
- C0011008
- UMLS CUI [2,3]
- C2745955
Beschreibung
Relevant Medical History/ Risk Factors not noted above
Datentyp
text
Alias
- UMLS CUI [1]
- C0012634
- UMLS CUI [2]
- C0035648
Beschreibung
Serious Adverse Events - Relevant diagnostic results
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0430022
- UMLS CUI-3
- C0456984
Beschreibung
Lab Sequence Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C2348184
Beschreibung
Test Name
Datentyp
integer
Alias
- UMLS CUI [1]
- C0022885
Beschreibung
Test Date
Datentyp
date
Alias
- UMLS CUI [1]
- C2826247
Beschreibung
Test Result
Datentyp
text
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Test Units
Datentyp
text
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Normal Low Range
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205251
Beschreibung
Normal High Range
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0086715
- UMLS CUI [1,2]
- C0205250
Beschreibung
Relevant diagnostic results not noted above
Datentyp
text
Alias
- UMLS CUI [1]
- C0587081
Beschreibung
Serious Adverse Events - Investigational Products
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0013230
Beschreibung
If Investigational product(s) stopped, did the reported event(s) recur after further investigational product(s) were administered?
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013230
- UMLS CUI [1,2]
- C1272691
- UMLS CUI [2,1]
- C1519255
- UMLS CUI [2,2]
- C0034897
Beschreibung
Serious Adverse Events - General narrative comments
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0947611
Beschreibung
Serious Adverse Events - Non clinical
Alias
- UMLS CUI-1
- C1519255
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C1298908
Beschreibung
Send incomplete SAE data to GSK Safety
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C1511726
- UMLS CUI [1,3]
- C0205257
Beschreibung
Receipt by GSK date
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2985846
Beschreibung
Was the event serious?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C1519255
Beschreibung
SAE Sequence Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1519255
- UMLS CUI [1,2]
- C2348184
Beschreibung
Version Number
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0333052
- UMLS CUI [1,2]
- C0237753
Beschreibung
Case ID
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1698493
- UMLS CUI [1,2]
- C0600091
Beschreibung
Randomisation Number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0034656
- UMLS CUI [1,2]
- C0237753
Beschreibung
OCEANS Code
Datentyp
text
Alias
- UMLS CUI [1]
- C0805701
Beschreibung
Email Flag
Datentyp
text
Alias
- UMLS CUI [1]
- C0013849
Beschreibung
Concomitant Medication
Alias
- UMLS CUI-1
- C2347852
Beschreibung
Sequence number
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348184
Beschreibung
(Trade Name preferred)
Datentyp
text
Alias
- UMLS CUI [1]
- C0013227
Beschreibung
Modified reported term
Datentyp
text
Alias
- UMLS CUI [1]
- C2826819
Beschreibung
GSK Drug synonym
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0871468
Beschreibung
GSK Drug Collection code
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C1516698
- UMLS CUI [1,3]
- C0805701
Beschreibung
Failed coding
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0805701
- UMLS CUI [1,2]
- C0231175
Beschreibung
Unit Dose
Datentyp
text
Alias
- UMLS CUI [1]
- C0869039
Beschreibung
Units
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Frequency
Datentyp
integer
Alias
- UMLS CUI [1]
- C3476109
Beschreibung
Route
Datentyp
integer
Alias
- UMLS CUI [1]
- C0013153
Beschreibung
Reason for Medication
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0013227
Beschreibung
Medication Start Date and Time
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826734
- UMLS CUI [2,1]
- C2347852
- UMLS CUI [2,2]
- C1301880
Beschreibung
Medication taken Prior to Study?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826667
Beschreibung
Concomitant medication ongoing?
Datentyp
boolean
Alias
- UMLS CUI [1]
- C2826666
Beschreibung
End date and time of concomitant medication
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826744
- UMLS CUI [2]
- C1522314
Beschreibung
Urinalysis - Local
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0205276
Beschreibung
Date and time sample taken
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [1,3]
- C0200345
Beschreibung
If Result of Dipstick is positive, provide details of repeated tests in the add entry section below.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0456984
Beschreibung
If Yes, provide details of repeated tests in the add entry section below.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C2700128
Beschreibung
Urine Dipstick - Laboratory Test
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0430370
- UMLS CUI [1,2]
- C0022885
Beschreibung
Urine Microscopy - Laboratory Tests
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0430397
- UMLS CUI [1,2]
- C0022885
Beschreibung
Laboratory Test Result - Numeric Result
Datentyp
float
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2347373
Beschreibung
Laboratory Test Result - Character Result
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C2350015
Beschreibung
Laboratory Test Result - No Result
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0042014
- UMLS CUI [1,2]
- C1274040
- UMLS CUI [1,3]
- C1298908
Beschreibung
Electronically Transferred Lab Data
Alias
- UMLS CUI-1
- C0200345
- UMLS CUI-2
- C0022885
- UMLS CUI-3
- C1320722
Beschreibung
Vital signs - Semi-supine
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0522019
Beschreibung
Vital Signs Semi-supine - Actual date/time
Datentyp
datetime
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C1264639
Beschreibung
Vital Signs Semi-supine - Blood pressure
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005823
Beschreibung
Vital Signs Semi-supine - Systolic blood pressure
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0871470
Beschreibung
Vital Signs Semi-supine - Diastolic blood pressure
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0428883
Beschreibung
Vital Signs Semi-supine - Temperature
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005903
Beschreibung
Vital Signs Semi-supine - Temperature
Datentyp
float
Maßeinheiten
- °C
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0005903
Beschreibung
Vital Signs Semi-supine - Heart rate
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0018810
Beschreibung
Vital Signs Semi-supine - Heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0018810
Beschreibung
Vital Signs Semi-supine - Respiration rate
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0231832
Beschreibung
Vital Signs Semi-supine - Respiration rate
Datentyp
integer
Maßeinheiten
- breaths/min
Alias
- UMLS CUI [1,1]
- C0439565
- UMLS CUI [1,2]
- C0522019
- UMLS CUI [2]
- C0231832
Beschreibung
Vital Signs - Standing
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-2
- C0231472
Beschreibung
Vital Signs Standing - Actual time
Datentyp
time
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0040223
Beschreibung
Vital Signs Standing - Systolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0871470
Beschreibung
Vital Signs Standing - Diastolic Blood Pressure
Datentyp
integer
Maßeinheiten
- mm[Hg]
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0231472
- UMLS CUI [2]
- C0428883
Beschreibung
Vital Signs Standing - Heart Rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C0018810
- UMLS CUI [2]
- C0231472
Beschreibung
12-Lead ECG
Alias
- UMLS CUI-1
- C0430456
Beschreibung
Date and Time of ECG
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschreibung
Heart rate
Datentyp
integer
Maßeinheiten
- beats/min
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
RR Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0489636
Beschreibung
PR Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0429087
Beschreibung
QRS Duration
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0429025
Beschreibung
Uncorrected QT Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C1287082
Beschreibung
QTc (b) Interval
Datentyp
integer
Maßeinheiten
- ms
Alias
- UMLS CUI [1]
- C0489625
Beschreibung
Method of QTc Calculation
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0855331
- UMLS CUI [1,2]
- C2911685
Beschreibung
Result of the ECG
Datentyp
integer
Alias
- UMLS CUI [1]
- C0438154
Beschreibung
ECG Abnormalities
Alias
- UMLS CUI-1
- C0522055
Beschreibung
Lead used for measurement
Datentyp
integer
Alias
- UMLS CUI [1]
- C1519795
Beschreibung
Date and Time of ECG
Datentyp
datetime
Alias
- UMLS CUI [1]
- C2826846
Beschreibung
(check all that apply)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0199556
Beschreibung
If other abnormal rhythm, enter comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0199556
- UMLS CUI [1,2]
- C1704258
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [2]
- C0947611
Beschreibung
(check all that apply)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C2216025
Beschreibung
If other P-Wave Morphology, enter comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2216025
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschreibung
(check all that apply)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0232217
Beschreibung
If other conduction, enter comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0232217
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschreibung
(check all that apply)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2]
- C0027051
Beschreibung
If other myocardial infarction, enter comment.
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0027051
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschreibung
(check all that apply)
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C2826293
- UMLS CUI [2,1]
- C1331539
- UMLS CUI [2,2]
- C0948857
Beschreibung
If other depololarisation/repolarisation, enter comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1331539
- UMLS CUI [1,2]
- C0948857
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C0947611
Beschreibung
If other abnormalities, enter comment
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0522055
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0947611
Beschreibung
Repeat Pharmacokinetics Blood - GSK618334
Ähnliche Modelle
Logs/ Repeats - Logs and Repeats; Non- Serious Adverse Events; Serious Adverse Events; Concomitant Medication; Electronically Transferred Lab Data; Vital Signs; 12-Lead ECG; ECG Abnormalities; Repeat- Pharmacokinetics Blood - GSK618334
C2985720 (UMLS CUI [1,2])
C0205341 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
C1516048 (UMLS CUI-4)
C2347852 (UMLS CUI-5)
C1516048 (UMLS CUI-6)
C0200345 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0205341 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,2])
C0031327 (UMLS CUI [1,2])
C0205341 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0304229 (UMLS CUI [2,1])
C2746065 (UMLS CUI [2,2])
C0243161 (UMLS CUI [2,3])
C0231175 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0439603 (UMLS CUI [1,2])
C0518690 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,2])
C2348184 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1705586 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C1522314 (UMLS CUI [2,2])
C0518690 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0441800 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C1519255 (UMLS CUI [2,1])
C0518690 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,2])
C0439849 (UMLS CUI [1,3])
C0449238 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C3174092 (UMLS CUI [1,3])
C1517741 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C2347852 (UMLS CUI-2)
C2348184 (UMLS CUI [1,2])
C2826744 (UMLS CUI [1,2])
C0012634 (UMLS CUI-2)
C0035648 (UMLS CUI-3)
C0262926 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,2])
C0035648 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
C0011008 (UMLS CUI [1,2])
C2745955 (UMLS CUI [1,3])
C0035648 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C2745955 (UMLS CUI [2,3])
C0035648 (UMLS CUI [2])
C0430022 (UMLS CUI-2)
C0456984 (UMLS CUI-3)
C2348184 (UMLS CUI [1,2])
C0205251 (UMLS CUI [1,2])
C0205250 (UMLS CUI [1,2])
C0013230 (UMLS CUI-2)
C1272691 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2,1])
C0034897 (UMLS CUI [2,2])
C0947611 (UMLS CUI-2)
C0205210 (UMLS CUI-2)
C1298908 (UMLS CUI-3)
C1511726 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C2348184 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,2])
C0871468 (UMLS CUI [1,2])
C1516698 (UMLS CUI [1,2])
C0805701 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C2347852 (UMLS CUI [2,1])
C1301880 (UMLS CUI [2,2])
C1522314 (UMLS CUI [2])
C0040223 (UMLS CUI [1,2])
C0200345 (UMLS CUI [1,3])
C2700128 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,2])
C2347373 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C2350015 (UMLS CUI [1,3])
C1274040 (UMLS CUI [1,2])
C1298908 (UMLS CUI [1,3])
C0022885 (UMLS CUI-2)
C1320722 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0200345 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0522019 (UMLS CUI-2)
C0522019 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0005823 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0005903 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0005903 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0018810 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0018810 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0231832 (UMLS CUI [2])
C0522019 (UMLS CUI [1,2])
C0231832 (UMLS CUI [2])
C0231472 (UMLS CUI-2)
C0231472 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2])
C0231472 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0231472 (UMLS CUI [1,2])
C0428883 (UMLS CUI [2])
C0018810 (UMLS CUI [1,2])
C0231472 (UMLS CUI [2])
C2911685 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,2])
C0199556 (UMLS CUI [2])
C1704258 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [2])
C2826293 (UMLS CUI [1,2])
C2216025 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C0232217 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C1331539 (UMLS CUI [2,1])
C0948857 (UMLS CUI [2,2])
C0948857 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
C0205394 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])